(26 days)
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALL Clear Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear
The CELERITY HP Indicator Tape (Indicator Tape) is a ¾'' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.
The provided document is a 510(k) premarket notification for a medical device called "CELERITY HP Indicator Tape (PCC077)". It does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document states, "No testing was required to verify the labeling change," and clarifies that "The revised labeling is in accordance with recommendations in 'User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry'' April 1, 2003." This implies that the current submission (K242189) is for a labeling change on an existing device, and therefore, no new performance testing was conducted for this specific submission.
The document also refers to the predicate device, K240760, and states that the proposed and predicate devices have "Identical" technological characteristics and performance limitations. This suggests that the performance criteria and related studies would have been established and demonstrated for the predicate device, and since the current device is identical in these aspects (apart from labeling), no new studies are needed.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document, as this submission primarily addresses a labeling change.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).